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Home > "A" Clinical Trials Conditions > A Study of Thioctic Acid and Deprenyl in HIV-Infected Patients with Dementia  A Study of Thioctic Acid and Deprenyl in HIV-Infected Patients with Dementia
A Study of Thioctic Acid and Deprenyl in HIV-Infected Patients with Dementia
For Condition: Cognitive Disorders,HIV Infections
Status: Completed
Sponsor(s): Charles A Dana Foundation ,
Synopsis: The purpose of this study is to see if it is safe and effective to give thioctic acid and deprenyl (selegiline hydrochloride), alone or in combination, to HIV-infected patients who have mild to moderate dementia (a decline in their mental abilities).
Details: Patients are randomized to receive thioctic acid alone, deprenyl alone, thioctic acid/deprenyl, or placebo alone for 10 weeks, after which all patients may receive active drug on an open-label basis. Patients must have seven clinic visits.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Antiretrovirals provided dose has been stable for at least 6 weeks prior to study entry. Patients must have: - HIV seropositivity. - Mild to moderate cognitive impairment (problems with short term memory, concentration, and feeling slowed down). - No active opportunistic CNS infection. - Ability to give informed consent. Prior Medication: Allowed: - Prior antiretrovirals provided dose has been stable for at least the past 6 weeks. - Prior thioctic acid or deprenyl. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Severe premorbid psychiatric illness including schizophrenia and major depression that would interfere with study compliance. - CNS neoplasms. - Any other clinically significant condition or laboratory abnormality that would preclude participation on study. - Current participation in other drug studies. Concurrent Medication: Excluded: - Chemotherapy for malignancy. Patients with the following prior conditions are excluded: - History of chronic neurological disorders such as serious head injury, documented stroke, multiple sclerosis, uncontrolled epilepsy, Tourette's syndrome, and other neurodegenerative processes such as Huntington's disease. - Prior participation in this study. - History of adverse reaction/allergy to thioctic acid or deprenyl. Prior Medication: Excluded: - Other investigational drugs within 30 days prior to study entry.
Total Enrollment: 32
Location and Contact Information:
Univ of Rochester Med Ctr
Rochester, New York, 14642
United States
Johns Hopkins Hosp
Baltimore, Maryland, 212876965
United States
Columbia Univ
New York City, New York, 10032
United States
Additional Information:
Study ID Numbers: 250A; 03-D95
Study Start Date:
Record last reviewed: March 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002154
Other Hiv Infections Studies:
1. Evaluation of the Safety and Tolerance of Immunotherapy With Autologous, Ex-Vivo Expanded, HIV-Specific Cytotoxic T-Cells in HIV-Infected Patients With CD4+ Counts Between 100-400/mm3
2. The Effects of Illnesses on HIV Levels in the Body
3. A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate With Leucovorin Protection for Patients With Pneumocystis carinii Pneumonia.
4. A Phase I Clinical Trial to Evaluate: Part A. The Safety of MTP-PE/MF59 Adjuvant Emulsion. Part B. The Safety and Immunogenicity of Env 2-3, a Yeast Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59
5. A Study to See Whether Two HIV Vaccines Are Safe and Can Prevent HIV Infection
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A Study of Thioctic Acid and Deprenyl in HIV-Infected Patients with Dementia
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